Skip To The Main Content
Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Pharmaceutical Microbiology Conference

4-6 October 2021

  • Yeissa Chabrier-Rosello

    Yeissa M. Chabrier-Rosello, PhD

    U.S. FDA
    Dr. Yeissa Chabrier-Roselló is a Senior Pharmaceutical Quality Assessor, in the Division of Microbiology Assessment/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research in the FDA. She has been a sterility assurance and product quality microbiology reviewer, served as a subject matter expert for FDA inspections as well as for different regulatory/compliance cases. Prior to joining the Agency, Dr. Chabrier-Roselló worked in the antimicrobial drug development and medical device fields. Dr. Chabrier-Roselló earned a Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine and Dentistry and a B.S. in Industrial Microbiology from the University of Puerto Rico at Mayagüez.
  • Mitch Garber

    Mitch B. Garber, BS, RPh

    bluebird bio
    Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio
  • Lynne Ensor

    Lynne A. Ensor, PhD

    PAREXEL International
    Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been a consultant to the biopharmaceutical industry since 2019. Her areas of expertise include sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, regulatory facility compliance, and regulatory policy development. Prior to consulting, Lynne was employed by the U.S. Food and Drug Administration for 21 years. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/Center for Drug Evaluation and Research and was responsible for new, generic, biologic and biosimilar drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Sciences’ New and Generic Drug Product Quality Microbiology staff, and Director of Office of Generic Drugs’ Division of Microbiology. Lynne’s previous experience includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.
  • Kurt Jaecques

    Kurt Jaecques, MA

    GlaxoSmithKline Vaccines
    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GlaxoSmithKline Vaccines

  • Simleen Kaur

    Simleen Kaur, MSc

    U.S. FDA
    CDR Kaur has a Masters in Biotechnology from Johns Hopkins University and Bachelors in Biology from the University of Delhi (India). She is currently stationed in Food and Drug Administration, under Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. She serves as a Team Leader for Laboratory of Microbiology In-vivo Testing and Standards where she manages production and distribution of CBER Reference materials used in potency testing of biological products such as vaccines prior to release to public. In addition, she reviews microbiological test methods used in the lot release of biological products as submitted in Biological License Applications and Supplements to ensure they are validated in accordance with Code of Federal Regulations and different pharmacopeia requirements.
  • Vineeta Pradhan

    Vineeta A. Pradhan, PhD

    U.S. FDA
    Vineeta Pradhan joined the Food and Drug Administration (FDA) in 2016 and is currently working as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). She reviews the pre- and post-approval CMC information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.

    Prior to joining the FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.

    Vineeta received her Ph.D. in Microbiology from The Ohio State University.
  • Christine Sherman

    Christine Sherman, BA

    Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, and vaccines. Prior to joining Takeda in 2017, she worked for several microbiology laboratories in the pharmaceutical industry including Johnson & Johnson, Pfizer and later, at Merck in a Sterility Assurance role for the vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental monitoring, process simulation, and smoke study programs, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently a member of the USP Expert Microbiology Committee.
  • Kim R. Sobien, MBA

    PETNET Solutions | A Siemens Company
    Kim Sobien is currently the Principal Sterility Assurance Engineer for PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the largest network of PET radiopharmacies worldwide.

    Previously she has served as an Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals. Her pharmaceutical industry career encompasses a breadth of experience with injectable pharmaceutical product Quality and Compliance, including pre-filled syringe generics, radiopharmaceuticals, and parenteral pharmaceutical contract manufacturing.

    Kim has a B.S. in Microbiology from the University of Wisconsin – La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is a member of the Parenteral Drug Association (PDA), past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology, and a member of the PDA Microbial Data Deviations (MDD) Technical Report writing team.
  • Lydia Troutman

    Lydia Troutman

    Merck & Co., Inc.
    Lydia Troutman, Director - Sterile Quality Assurance and Microbiology, Merck & Co.
    Develope and implement healthcare compliance program policies, guidelines,, procedures and training initiatives. Provide healthcare compliance communications, guidance and interpretation to commercial, medical affairs, and research and development departments.
    30+ years of progressive experience in sterile and non-sterile pharmaceutical industry with extensive focus on Quality Assurance and Compliance at international level.
    Member of PDA • Participating Author for PDA Technical Bulletin #13, Fundamentals of Microbiological Monitoring Program • Member of (PMED) Professional Microbiology, Education, and Discussion Group • Member of (HBA) Healthcare Business Women’s Association • Member of (WOCIP) Women of Color in Pharma
  • MaryEllen Usarzewicz

    MaryEllen E. Usarzewicz, MS

    Bristol-Myers Squibb
    MaryEllen E. Usarzewicz received her B.S. in Microbiology from Wagner College in 2000. After several years working in CRO’s, she joined BMS in 2007, eventually ending up, through various roles as Associate Scientific Director, Microbiological Support Operations. She oversees a group that is responsible for providing microbiological support of non-sterile and sterile clinical manufacturing operations including environmental monitoring, drug product testing and facility qualifications. She is active in several teams in the Parenteral Drug Association. In her spare time, she is busy raising 2 children.
  • Friedrich von Wintzingerode

    Friedrich von Wintzingerode, PhD

    Genentech Inc
    Friedrich is QC Lead of iNeST (individual Neoepitope Specific Therapy) project located in South San Francisco, CA.

    After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany. 

    He joined Roche in 2001 working as Micro lab Manager and Senior Manager on various topics (environmental monitoring, biochemical cleaning analytics, microbiological IPC and analytics for release, endotoxin testing, LER). Friedrich led several Roche-Genentech Micro expert teams (e.g. identification, microbiological testing) and co-chaired the PDA LER Task Force. He chaired and co-chaired several Endotoxins and Pyrogen Sessions at Pharmalab and PDA. Before starting his current position he was Senior Manager at Roche-Genentech Global QC and Head of Roche-Genentech global Endotoxin Expert Group and Roche-Genentech global SME on microbial impurity contaminations and LER.
  • Jason Willett

    Jason L. Willett

    Veltek Associates, Inc.
    Jason Willett is currently the Midwest Manager for Veltek Associates Inc., providing contamination control products and services to the pharmaceutical, biotech, and healthcare industries. In this position, Jason regularly consults with pharmaceutical manufacturers in the areas of cleaning, disinfection, aseptic practices, environmental monitoring and regulatory expectations. With over 20 years of relevant experience, Jason is able to help customers develop compliant and cost effective contamination control programs. In addition to his responsibilities at Veltek, Jason is a volunteer on the PDA’s Exhibit Committee and Treasurer for the PDA Midwest Chapter.

    Jason graduated from the University of Cincinnati with a bachelor’s degree in Chemistry and lives near Cincinnati, OH with his wife, Leslie, and three children, Ella, Laney and Matthew.
  • ZivaAbraham

    Ziva Abraham, PhD

    Microrite, Inc.
    Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi towards her Ph.D degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
  • blank-profile

    Susan L. Ashley, PhD

    Merck & Co., Inc.
    Susan Ashley has a bachelor’s degree in Pharmacy and doctorate in Pharmaceutics. She has more than 25 years of experience in global drug development, manufacturing, and strategy. Susan has worked for Merck, Pfizer Animal Health (formerly SmithKline Beecham Animal Health), and Marion Merrell Dow. Her areas of expertise and experience include quality control testing and release; semi-solid and solid dosage form design, scale up, technology transfer, and full-scale process validation; regulatory CMC; project management; sterile supply support; single-use component design and support for large molecule and sterile manufacturing; process simulation for sterile products; and aseptic behavior and technique training. She currently leads the Aseptic Training Initiative within Merck and has been responsible for developing and delivering a standard aseptic training curriculum for the Global Merck Sterile Network.
  • Tiffany Baker

    Tiffany A. Baker, MBA

    ValSource Inc.
    Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
  • Marcia Baroni

    Marcia C. Baroni, MBA

    Emergent BioSolutions
    With over 20 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality Operations for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for Quality Operations across five of Emergent's manufacturing sites across Canada, the US and Switzerland. Marcia is a Microbiology graduate from the University of Toronto and recently completed her MBA from Purdue University.
  • Rafael Beaus

    Rafael Beaus

    Azbil Telstar
    Rafael Beaus, Global Consultancy Manager at Azbil Telstar holds a Bachelor of Pharmacy from the University of Barcelona (1988), PDG (General Management Program, 2002) from IESE(Barcelona) and Industrial and Pharmacy Technology specialist (2001). Rafa is also an Academic of the Royal Catalan Academy of Pharmacy (2016). He has more than 30 year’s industry experience; 10 years at AlconCusi Laboratories as Head of the factory for solid and liquid forms (4 years) and Head of Quality Assurance and Technical Director (6 years). In 1998, he started in consultancy activity as MD of SVS, internationalizing the company and making it grow until its integration into the Telstar group, where he has held varied roles in local and global markets. Rafa is currently working at Azbil Telstar as Global Consultancy Manager where he lecturers at many specialized courses worldwide on sterile production, pharmaceutical utilities, quality assurance and general production. He has also been a key trainer for the Spanish Medicine Agency on several topics.
  • Dan Bice

    Dan J. Bice

    Dan J. Bice, Associate Director Quality Control Operations, Adaptimmune
  • Renee Blosser

    Renée S. Blosser, MS

    U.S. FDA

    Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Jay Bolden

    Jay S. Bolden

    Eli Lilly
    Mr. Jay Bolden is an Associate Quality Advisor-Biologist in the Eli Lilly and Company Global Quality Laboratories. He is an internal endotoxin subject matter expert and leads a team with global QC oversight for developing, validating, transferring and troubleshooting endotoxin, microbiology, QPCR and ELISA methodologies. Jay holds a B.S. in Biology and an Environmental Studies certificate from Indiana University, and has over 21 years of industry experience in development, process and laboratory microbiology, and microbiology laboratory leadership.
  • Kenneth Boone

    Kenneth W. Boone

    Merck & Co., Inc.
    Ken Boone is a Director of Sterile & Microbiology Quality Assurance within the Global Compliance group at Merck. His current responsibilities include sterility assurance and aseptic processing for Merck sites globally that produce sterile and low bioburden products and to ensuring sites' compliance with current regulatory guidelines and expectations. Before Merck, Ken had a variety of global and site-based microbiology, aseptic processing, and sterility assurance responsibilities for Novartis, Mallinckrodt, Cardinal Health, and Pfizer. He has been a member of PDA since 2002 and is a founding member and former President-elect of the PDA Missouri Valley Chapter and currently President-elect of the PDA Southeast Chapter. Ken is a graduate of the University of Kansas.
  • Jette Christensen

    Jette Christensen, MSc

    Novo Nordisk A/S

    Jette Christensen works at Novo Nordisk A/S where she has held several different positions. She currently serves as the Scientific Director of Biopharm Manufacturing Development. In this position she is responsible for setting cross functional directions within supporting process areas and for driving continuous improvements. In the past her main focus has been on the aseptic processing area and also on quality processes. Currently she is among others heading up a project about implementation of CCS for all Novo Nordisk facilities. She has more than 20 years’ experience within the pharmaceutical industry.

    Jette has been active in PDA for several years. She has been member of several task forces preparing documents covering the aseptic area, been member of Science Advisory Board and currently she is Chair for the Board of Directors.

  • Tamara Garcia-armisen

    Tamara Garcia-armisen, PhD

    GSK Vaccines- Living Viral Vaccines Manufacturing
    Tamara Garcia-Armisen is a senior scientist currently in charge of the Sterility Assurance and contamination control strategy for aseptic manufacturing of viral vaccines bulk (Biologicals) at GSK. She holds a Master in Microbiology and Molecular biology and a PhD in Microbiology from the ULB (Free University of Brussels). Tamara has over 20 year of academic and industrial experience in Microbiology and Quality Assurance. Previous roles included microbiology and sterility assurance expert for QC and QA in plasma-derivate products manufacturing; Research Scientist in Sterility assurance for medical devices for the validation of sterilization and disinfection strategies and Academic researcher authoring more than 20 papers in peer reviewed journals in Environmental Microbiology and water contamination topics. This experience across different fields, different products and lifecycle steps and different companies allow her to have a complete vision of the main challenges of the industry for the next years in the Contamination control and sterility assurance topics.
  • Miriam Guest

    Miriam Guest


    Miriam Guest is an Associate Principal Scientist, Microbiology at AstraZeneca, working in the New Modalities and Parenteral Development group; based at their Macclesfield site in the UK. Miriam has worked in Pharmaceutical Development for over 20 years, in both microbiology & formulation laboratories and GMP manufacturing environments; more recently supporting complex supply chains and designing robust control strategies, including the associated regulatory authoring & interactions.

    She leads the AZ Global Microbiology Forum, bringing together a global network to drive standardisation and quality principals in Microbiology.

    Miriam devised & leads AstraZeneca’s “21st Century Microbiology Strategy”, to innovate, industrialise and implement technology solutions to drive efficiencies and process robustness benefits within the AZ global network. Miriam has led many cross site improvement projects, one of which was awarded the AZ Global Operations Award for Performance in 2019.

    She is an active committee member of the Pharmaceutical Microbiology Interest Group (Pharmig) and co-chairs the Cross Industry Consortium on Modernisation of Microbiology.

  • blank-profile

    Cindy M. Heath

    Eli Lilly
    Cindy Heath is a Senior Research Scientist at Lilly with expertise in laboratory process automation. She began her career at Hologic, supporting the development and launch of a fully automated infectious disease test platform. She then moved to Dow, where she implemented a high-throughput automation platform for microarray and Next-Generation Sequencing, followed by an Application Scientist role at Beckman Coulter Life Science guiding automation of their nucleic acid extraction portfolio. In her current role, she continues her passion for advancing automated solutions for the Global Quality Laboratory organization. She holds a Bachelor of Science in Molecular Biology from the CSUSM.
  • Brooke K. Higgins, MS

    U.S. FDA
    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, preparing associated regulatory actions, and providing training to ORA and CDER personnel. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.
  • Dan Klein

    Dan A. Klein, MA

    STERIS Corporation
    Dan Klein currently holds the position of Senior Technical Service Manager at STERIS Corporation and has extensive experience in the antimicrobials industry. This experience includes over 20 years as a R&D Manager of Microbiology and Clinical affairs as well as management of a contract testing laboratory. His technical expertise includes supporting multiple areas including pharmaceutical, healthcare and Department of Defense projects. He specializes in microbiology, regulatory affairs, disinfectant applications, experimental testing and design.
  • Stephen Langille

    Stephen E. Langille, PhD

    ValSource, Inc.
    Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection of Parenterals Expert Panel as well as several Parenteral Drug Association technical committees.
  • Anna Lau

    Anna F. Lau, PhD, D(ABMM)

    National Institutes of Health
    Dr. Lau is the Chief of the Sterility Testing Service at the NIH Clinical Center where she leads the core microbiology testing laboratory that supports the NIH-wide cGMP aseptic processing and manufacturing of cellular therapy and drug pharmaceuticals for NIH clinical protocols. Dr. Lau received her Ph.D. from the University of Sydney, Australia. She completed her CPEP Clinical Microbiology Fellowship training at the NIH Clinical Center and is board-certified through the American Board of Medical Microbiology. Dr. Lau's translational research focuses on the development of new rapid diagnostic platforms for microbial identification and the detection of resistance mechanisms using molecular-based techniques and mass spectrometry. In 2014, Dr. Lau was recognized with the prestigious Forbes 30 Under 30 award in Science and Healthcare for her development of the NIH Mold MALDI-TOF MS Database. In her current role, Dr. Lau assists in bridging the gap between cGMP expectations and clinical microbiology labs that are involved with hospital pharmacy testing as well a ATMPs as cell gene therapies become more readily available in academic hospital settings.
  • Joseph McCall

    Joseph E. McCall, SM (NRCM)

    ADMA Biologics
    Joe McCall, SM (NRCM) is the Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology for companies in Europe, Asia, South America, and across the US. He has been a proud member of PDA for nearly 20 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
  • John Metcalfe

    John W. Metcalfe, PhD

    U.S. FDA

    Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island.  John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003.  At FDA, John works as a microbiologist where he performs a review of both sterile and non-sterile drug products providing an assessment of microbiological quality.  He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding, and is a published author in the area of drug product microbiological quality.

  • Michael J. Miller, PhD

    Microbiology Consultants, LLC
    Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC ( and owner of, a website dedicated to the advancement of rapid methods within healthcare related industries.

    For 30+ years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller provides technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control and GMPs.

    Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr. Miller is the chairperson for PDA's Technical Report #33 and currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

    Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University.